evaluation of the efficacy and safety of the dermal filler for augmentation of labia majora.

Conditions: Labia Majora Atrophy and Hypotrophy

Summary: the study is an open-label uncontrolled single-center study for the evaluation of the performance characteristics (efficacy and safety) of the dermal filler "mmi-22-04-2019" on the female genital area for the aesthetic, medicinal, functional and reconstructive indications.

mmi-22-04-2019 is a dermal filler recommended for application in the intimate area. it is a sterile, injectable, colorless transparent gel, non-pyrogenic, reabsorbable medical device. its main functional ingredient is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation. the mmi-22-04-2019 is contained in pre-filled, graduated, disposable sterile syringe with luer lock adapter with 1 ml of net content. the sterilization of the product is achieved by moist heat. the mmi-22-04-2019 has been classified as a class iii medical device under annex ix of directive mdd 93/42 eec since it is a long-term, invasive and absorbable medical device.

Eligibility criteria:
inclusion criteria: * female subject aged ≥18; * subject presenting vulvar ptosis, deflation or aesthetic discomfort in the intimate area; * subject who presents no type of pathology of the area to be treated; * subjects who are willing to abstain from any cosmetic or surgical procedures in the treatment area during the clinical investigation; * clinically and anamnestically healthy individual; * absence of a history of significant hypersensitivity to food and drugs or known sensitivity to hyaluronic acid; * arterial blood pressure (bp) (after 5 min. at rest in the supine position) systolic 90 - 140 mmhg and diastolic 50 - 90 mmhg; * heart rate (hr) (after 5 min. at rest in the supine position) over 50 beats/min and less than 90 beats/min; * respiratory rate between 12 - 24 breaths/min; * axillar body temperature of up to 370с; * clinical-laboratory examinations within the reference ranges or with no clinically significant abnormalities; * negative aids/hiv test; * negative pregnancy test for the women with reproductive potential; * reliable and acceptable method of contraception for the women of child-bearing potential * signed written informed consent form. exclusion criteria: * subject with known sensitivity to hyaluronic acid or significant hypersensitivity to food and drugs; * subject with history of vulvar cancer and/or previous regional radiotherapy; * subjects with frequent or present active herpes simplex or herpes zoster local infection or active herpes simplex or herpes zoster infection in other sites; * subjects with history of frequent or active local dermatitis (of the injection site), vulvar scaly papilloma, mycosis; bacterial infection; * subjects suffering from autoimmune diseases or who are undergoing treatment with immunosuppressors or immunotherapy; * subjects uncontrolled systemic diseases; * pregnancy, postpartum period (6 months) or post-lactation period (6 months); * absence of a reliable and effective method of contraception; * subjects who are currently receiving another investigational treatment or who had participated in another clinical investigation within 30 days prior to study enrollment; * subjects who suffer from another medical condition or who are receiving medication that in the principal investigator's judgment would prohibit inclusion in the study; * subjects with limited mental activity and consistent comprehension ability; sportsmen and individuals on strenuous physical loading; prisoners; * refusal to sign the informed consent form.